Chronic Pain Clinical Trial
Official title:
The Role of Varenicline in Treating Opioid Dependence: A Pilot Study
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion criteria - Age>=21 years - Use of opioids at admission to PRC, with daily morphine equivalent dose>=60mg - Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC - Ability to provide informed consent Exclusion criteria - Currently using varenicline or other pharmacotherapy for nicotine dependence - Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception; - History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty; - Known varenicline allergy - Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction - Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | assessment of opioid withdrawal symptoms | During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning | 45 days | Yes |
Primary | Assessment of cravings at one month following opioid tapering | During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning | 45 days | Yes |
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